Kornimate/medical-research-clean huggingface dataset:
effect of cryotherapy on postoperative pain

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Eligibility criteria:
inclusion criteria: * age between 20-40 years old. * systemically healthy patient (asa i or ii). * mandibular first molar teeth with: * preoperative sharp pain and symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (pdl). .vital response of pulp tissue to cold pulp tester (ethyl chloride spray). * ability for isolation with rubberdam. * restorable teeth * ability to fill the root canals in single visit treatment. exclusion criteria: * teeth without good apical constriction, such as wide or open apex * use of any type of analgesics or antibiotic medications within 3 days .pregnant or nursing females. * patients having significant systemic disorder (asa iii or iv). * teeth that have : non vital pulp tissues. association with swelling or fistulous tract acute or chronic periapical abscess greater than grade i mobility pocket depth greater than 5 mm no possible restorability
diffusion weighted magnetic resonance imaging of the breast during chemotherapy: response evaluation

Conditions: Breast Cancer

Summary: evaluation of the response to chemotherapy in breast cancer patients by the use of diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.


Eligibility criteria:
inclusion criteria: * core biopsy with diagnosis of breast cancer * start of neo-adjuvant chemotherapy exclusion criteria: * magnetic resonance imaging incompatibility

Keywords: diffusion-weighted magnetic resonance imaging
activity monitoring assessment of opiate withdrawal - 4

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine if hyperactivity accompanies abrupt opiate withdrawal in heroin addicts, to determine if computerized solid state activity monitors are capable of quantifying hyperactivity, and to quantify the physical and affective symptoms occurring during abrupt withdrawal in heroin addicts and morphine's capacity to alleviate these symptoms.


Eligibility criteria:
please contact site for information.

Keywords: opioid dependence
long-term study that measures the safety and efficacy of deucravacitinib (bms-986165) in participants with psoriasis

Conditions: Psoriasis

Summary: the main purpose of this study is to characterize the long-term safety and efficacy of the drug deucravacitinib (bms-986165) in patients who have been previously enrolled in an applicable phase 3 psoriasis study.


Eligibility criteria:
inclusion criteria: * completion of the protocol-required treatment period in an applicable study of bms-986165 in moderate-to-severe psoriasis * women must not be pregnant, lactating, or breastfeeding exclusion criteria: * any disease or medical condition that the investigator feels that would make the patient unsuitable for this study. * to be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (tb) as judged by the investigator. other protocol-defined inclusion/exclusion criteria apply

Keywords: psoriasis
safety and efficacy of pg102p for uremic pruritus in hd patients

Conditions: Uremic Pruritus

Summary: in this study (snug trial), the investigators aim to investigate the anti-pruritic effect of pg102p in comparison with placebo in 80 patients undergoing hd.

this is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with pg102p (1.5 g/day) and the other with a placebo. it is an investigator-initiated clinical trial. a superiority trial is planned to test the hypothesis that pg102p is effective in relieving pruritus for patients with esrd undergoing hd.

Eligibility criteria:
inclusion criteria: 1. age over 19 years 2. patients with adequate hd (kt/v \> 1.2) 3. maintenance patients undergoing hd with chronic pruritus 4. mean visual analog scale (vas) over 4 of the last 5 days in the 14-day pre-observation period 5. participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period 6. patients who agreed to participate in this trial and had written an informed consent exclusion criteria: 1. intact parathyroid hormone (ipth) \> 1000 pg/ml within 1 month 2. serum potassium \> 7.0 mg/dl 3. hiv ab (+) 4. aspartate transaminase (ast) (glutamic oxaloacetic transaminase) or alanine transaminase (alt) (glutamic pyruvic transaminase) \> 3 times the upper limit of normal 5. scheduled to have kidney transplantation within 3 months 6. cancer history with current treatment 7. active infection with current treatment 8. current itching with dermatologic diseases other than uremic pruritus 9. pregnancy, childbearing potential during the study period, or breastfeeding 10. allergy or hypersensitivity reaction to pg102p 11. history of participating another clinical trial within 2 months or planning to participate another clinical trial 12. not eligible to participate this trial as researchers' decision

Keywords: uremic pruritus hemodialysis
the japan-combined treatment with olmesartan and a calcium channel blocker versus olmesartan and diuretics randomized efficacy study (j-core)

Conditions: Hypertension

Summary: the purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (bp) and reducing target organ damage in japanese hypertensive patients: angiotensin ii receptor blocker (arb) plus calcium channel blocker (ccb) or arb plus diuretics.

renin-angiotensin (ra) inhibitors have been demonstrated to be the most effective drugs for reducing subclinical target organ damage in hypertensive patients. in several patients, however, bp control is not sufficiently achieved by ra inhibitors alone, and a combination of two drugs is frequently required. it is unclear whether a combination of ra inhibitors and diuretics or ccb is more effective in reducing hypertensive target organ damage. control of central bp has been shown to be more effective than peripheral bp in predicting cardiovascular events and target organ damage associated with hypertension. the j-core study is active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (probe) design study. the arb plus ccb combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day and the arb plus diuretics combination therapy group receives olmesartan 20 mg/day and hydrochlorothiazide (hctz) 12.5 mg/day. at least 100 patients will be enrolled in each group and the follow up duration will be 24 weeks. the primary endpoint is to compare the changes in the central aortic bp and the ambulatory bp between the two groups. the secondary endpoint is to compare the changes in office bp, home bp, and hypertensive target organ damage between the two groups.

Eligibility criteria:
inclusion criteria: * hypertensive outpatients aged 30 years or older, and less than 85 years (at the time of informed consent), regardless of sex * office systolic bp/diastolic bp \> 140/90 mmhg in a sitting position even if on treatment with olmesartan 20 mg/day for 3 months. exclusion criteria: * secondary hypertension or malignant hypertension * history of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening * percutaneous transluminal coronary angioplasty (ptca) or coronary artery bypass grafting (cabg) done within 6 months of screening or scheduled * current treatment for congestive cardiac failure (new york heart association \[nyha\] functional class ii or severer) or ejection fraction \<40% * atrial fibrillation or atrial flutter * renal dysfunction (serum creatinine ≥2 mg/dl) * hepatic dysfunction (ast and/or alt ≥100 iu/l)
a dose finding study of tkm-080301 infusion in neuroendocrine tumors (net) and adrenocortical carcinoma (acc) patients

Conditions: Cancer; Neuroendocrine Tumors; NET; Adrenocortical Carcinoma; ACC

Summary: this study will be a phase i/ii, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. the study is designed to determine the safety, tolerability and pk of tkm-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. after the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (net) or adrenocortical carcinoma (acc) tumors.


Eligibility criteria:
inclusion criteria: * patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-hodgkin's lymphoma or hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. for the neuroendocrine (net) and adrenocortical carcinoma (acc) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per recist 1.1) net or acc tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy. * patient has an ecog performance status of 0 - 1, * patient has adequate hematologic, hepatic and renal function, * patient is seronegative for hepatitis b virus (hbv) and hepatitis c virus (hcv), * patients must have a life expectancy of at least 12 weeks. exclusion criteria: * unresolved toxicities (\> grade 1) of previous chemotherapy, * patients with primary tumors of the central nervous system (cns), * prophylactic hematologic growth factors administered \</= 2 weeks prior to start of therapy, * patient has history of or existing clinically significant cardiovascular disease, * patient has a history of clinically significant asthma or copd requiring daily medication within the last 6 months, * patient has a seizure disorder not controlled on medication, * patient has a known or suspected viral, parasitic, or fungal infection, * patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products, * patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.

Keywords: solid tumor non-hodgkin's lymphoma hodgkin's disease neuroendocrine tumors (net) adrenocortical carcinoma (acc) carcinoid
a study to evaluate the efficacy and safety of vytorin versus standard treatment of other statins in moderate, moderately high and high risk participants (mk-0653a-406)

Conditions: Dyslipidemia

Summary: this study will evaluate and compare the effectiveness of mk-0653 (vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.


Eligibility criteria:
inclusion criteria: * low-density lipoprotein cholesterol (ldl-c) ≥100 mg/dl * either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment exclusion criteria: * ldl-c level ≥ 190 mg/dl * hypersensitivity or intolerance to vytorin, ezetimibe or simvastatin * taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc) * pregnant or breastfeeding, or expecting to conceive within the projected duration of the study * currently participating in or has previously participated in a study within 30 days * congestive heart failure defined by new york heart association (nyha) class iii or iv within previous 6 months * uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ecg) changes * unstable angina pectoris * myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months * unstable or severe peripheral artery disease within previous 3 months * uncontrolled hypertension (treated or untreated) * type 1 or type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months) * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months * received treatment with systemic corticosteroids, any cyclical hormones within previous 8 weeks
study of melphalan hcl for injection (propylene glycol-free), carmustine, etoposide, cytarabine (beam regimen) and autologous stem cell transplantation for lymphoma

Conditions: Hodgkin Disease; Lymphoma, Non-Hodgkin

Summary: phase ii study is being conducted to confirm the safety and efficacy of high-dose melphalan hcl for injection (propylene glycol-free) when included in the beam regimen for myeloablative conditioning in lymphoma patients undergoing asct


Eligibility criteria:
inclusion criteria: * diagnosis of hodgkin lymphoma or non-hodgkin lymphoma. * eligible for autologous stem cell transplantation. * 18 to 75 years of age at time of enrollment. * adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10\^6 cd34+ cells/kg based on patient body weight * ecog performance status ≤ 2 * normal organ function as defined below: * creatinine clearance \> 40 ml/min * total bilirubin ≤2.0 x iuln * ast(sgot)/alt(sgpt) ≤ 3.0 x iuln * lvef \> 40% (by echo or muga) * fev1 \> 50% of predicted and dlco \> or = 50% of predicted * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * able to understand and willing to sign an irb approved written informed consent document. exclusion criteria: * a history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment. * a history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan hcl for injection (propylene glycol-free), captisol, or other agents used in the study. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or breastfeeding women. women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry. * known hiv-positivity. these patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .
evaluation of ceftaroline fosamil vs vancomycin plus aztreonam in the treatment of patients with skin infections.

Conditions: Complicated Skin and Soft Tissue Infection

Summary: the purpose of this study is to evaluate the effects of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

a phase iii, multicentre, randomised, double-blind comparative study to evaluate the efficacy and safety of ceftaroline fosamil (600 mg every 8 hours) versus vancomycin plus aztreonam in the treatment of patients with complicated bacterial skin and soft tissue infections with evidence of systemic inflammatory response or underlying comorbidities

Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or older - complicated skin and skin structure infection (cssti) - infection of sufficient severity to warrant hospitalization - infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for mrsa that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose. exclusion criteria: * received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug - uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens - diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease - infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb - chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock

Keywords: complicated skin and soft tissue infections (cssti) skin infection ceftaroline wound infection cellulitis burn infection bacterial infection vancomycin
study to evaluate the effects of mbx-8025 in patients with hofh

Conditions: Homozygous Familial Hypercholesterolemia

Summary: a 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of mbx-8025 in patients with homozygous familial hypercholesterolemia (hofh).

open-label, single arm, non-controlled, dose ascending (50 mg/day, 100 mg/day and 200 mg/day) with three consecutive dose escalation periods. after signing an informed consent subject will enter a screening period and a run-in stabilization period. at the end of run-in period patients will enter treatment phase. mbx-8025 in ascending doses (50 mg, 100 mg, and 200 mg) will be given within three consecutive 4 weeks periods, for a total of 12 weeks. at the end of treatment, subjects will enter a follow-up period.

Eligibility criteria:
inclusion criteria: 1. must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements. 2. male or female with hofh confirmed by genotype (two mutant alleles at the ldl-receptor (ldl-r) gene locus or double heterozygotes ldl-r/apo-b). 3. 18 years of age or older. 4. existing lipid lowering therapies (statins, cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid and their combinations, low-density lipoprotein (ldl) ldl-c apheresis) on a stable regimen for at least four weeks before screening visit. 5. stable lipid lowering diet compatible with a step i diet of the american heart association (aha). 6. fasting ldl-c ≥ 4.8 mmol/l (≥ 185.6 mg/dl) during screening. 7. for females or males of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. exclusion criteria: 1. treatment with lomitapide or mipomersen within two months of screening. 2. heart failure (hf) with new york heart association (nyha) class iii and class iv or a left ventricular ejection fraction (lvef) of less than 30%. 3. uncontrolled cardiac arrhythmia during the past three months of screening. 4. myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke during the past three months of screening. 5. planned cardiac surgery, or planned revascularization, in the next four months. 6. uncontrolled hypertension. 7. aspartate transaminase (ast) or alanine transaminase (alt) ≥ 3 times the upper limit of normal (uln). 8. unexplained creatine kinase (ck) ≥ 5 times the upper limit of normal (uln). 9. for females, pregnancy or breast-feeding. 10. any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study as judged by the investigator and/or medical monitor.

Keywords: hofh
safety and effectiveness of visipaque 320mg-i/ml for use in contrast-enhanced ct angiography of arteries of the heart

Conditions: Coronary Artery Disease

Summary: ct (computed tomography) angiography (cta) is an examination similar to a cat scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body. visipaque™ will be given through a vein in the arm before having the cta scan of the heart arteries. the pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the cta shows the same blockages.


Eligibility criteria:
inclusion criteria: * subject is ≥18 years old. * subject must have been referred for an elective coronary angiography for one of several specified conditions. exclusion criteria: * the subject has impaired renal function with a serum creatinine level ≥1.7 mg/dl (150 µmol/l). if the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dl (150 µmol/l), the investigator should follow the practising guideline(s) of their institution. subject has a known allergy to iodinated contrast agent subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac ct images. the subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated. use of nitroglycerin is contraindicated. subject has had a prior cabg procedure. subject has a metal cardiac stent in place or artificial heart valve(s). subject has had a prior pacemaker or internal defibrillator lead implantation. subject must agree to discontinue metformin day of and for 48 hours after the cta procedure.

Keywords: coronary angiography x-ray cad